Implant in the form of a wound cuff electrode assembly

ABSTRACT

The invention has a contact assembly including a spatial longitudinal extension which is orientated parallel to the winding axis. The contact assembly is fixedly joined to the carrier substrate along a joining region which has a joining region length orientated in parallel to the winding axis. The orthogonal projection relative to the winding axis overlaps with a first region of the carrier substrate which is wound into a tube.

CROSS REFERENCE TO RELATED APPLICATIONS

REFERENCE IS MADE TO PCT/EP2019/054643 FILED Feb. 26, 2019, DESIGNATING THE UNITED STATES, WHICH CLAIMS PRIORITY TO GERMAN APPLICATION NO. 10 2018 204 036.2 FILED Mar. 16, 2018, WHICH ARE INCORPORATED HEREIN BY REFERENCE IN THEIR ENTIRETY

BACKGROUND OF THE INVENTION Field of the Invention

The invention relates to a medical implant wound cuff electrode assembly. Extravasal or extra-neuronal fastening is used along an intracorporeal vessel or a nerve fibre bundle, having a flexible, biocompatible, film-like carrier substrate. A first region assumes a tube form wound about a winding axis. The tube has a straight, cylindrical cavity which is radially delimited relative to the winding axis by a surface of the carrier substrate on which the at least one electrode surface is mounted. The surface is connected via at least one electrical line integrated within the carrier substrate to a non-flexible contact assembly.

Description of the Prior Art

Cuff electrodes of the aforementioned type are usually applied to record and also to apply electrical signals from/to intracorporeal vessels, in particular to nerve bundles. For this, cuff electrodes have a flexible, biocompatible carrier substrate, on the surface of which facing the nerve bundle at least one, preferably a plurality of electrodes is applied which has to be joined in intimate physical contact to the surface of a nerve bundle.

A cuff electrode of this type is disclosed in WO 2016/055512 A1. The carrier substrate of the cuff electrode comprises a polyimide film, which for the purpose of at least section-wise automatic winding about a winding axis, has undergone mechanical film pre-tensioning. Through the process of winding the cuff electrode about the nerve bundle, the individual electrodes of the cuff electrode come into direct surface contact with the epineurium of a nerve fibre bundle. By way of a force-applied form-fitting connection, the cuff electrode attaches itself to the nerve fiber bundle. The carrier substrate regions become overlapped through the rolling up or a winding process to lie on each other in a loosely sliding manner.

The electrical lines leading from the individual electrodes of the cuff electrode each extend, are electrically insulated, within the polyimide film and end at a side edge area of the polyimide film which is spatially separated from the wound region of the cuff electrode. The ends of the electrical lines are each connected via an electrical contact assembly to electrical feed and discharge lines, via which the cuff electrode is connected to an implantable electrical supply unit, which is located intracorporeally to be separated from the cuff electrode.

Because of the natural sensitivity of nerve fibers to external mechanical influences, the mechanical loads acting on the nerve fiber bundle must be kept as low as possible. On the other hand it must be ensured that the cuff electrode surrounds the nerve fiber bundle stably enough to guarantee as durable and fixed joining of the cuff electrode along the nerve fiber bundle as possible.

Practical experience with the use of cuff electrodes shows, on the one hand, that through the loose winding of the carrier substrate, sometimes in multiple layers, around a nerve fiber bundle, a dynamic radial expansion of the cuff electrode is possible, through which the cuff electrode is able to adapt to natural changes in shape of the nerve fiber bundle, while on the other hand external forces acting on the cuff electrode can significantly deform its winding geometry through which the nerve fiber bundle can be exposed to considerable mechanical stresses which could lead to irreversible damage.

DE 44 33 111 A1 describes a cuff electrode comprising a flexible, multiple-layer substrate of non-conductive silicone on which there are raised electrodes made of conductive silicone. The conductor paths leading to the electrodes run between the non-conductive layers and are also made of conductive silicone. The setting of different pre-stresses in the multiple-layer structure of the cuff electrode brings about the rolled-up form of the cuff electrode.

SUMMARY OF THE INVENTION

The invention is a cuff electrode which has a flexible, biocompatible, film-like carrier substrate, which in a first region, through being wound about a winding axis, assumes the form of a tube which comprises a straight, cylindrical cavity. The cavity is delimited radially relative to the winding axis by a surface of the carrier substrate on which the at least one electrode surface is mounted, which is connected via at least one electrical line integrated within the carrier substrate to a non-flexible contact assembly on which the at least one electrical line is connected to at least one of an electrical feed and discharge line which leads to an implantable electrical supply unit formed separately from the implant by the simplest way to ensure that the cuff electrode exerts a force or pressure effect on the nerve fiber bundle which is as even and gentle as possible. This should apply in particular to those cases in which the cuff electrode is stressed by tensile forces acting along the electrical feed and discharge lines, caused by the body's own movements.

In accordance with the invention, the medical implant is a wound cuff electrode assembly is characterised by the contact assembly being firmly joined to the carrier substrate along a dimensionally stable joining region. The joining region has a spatial length which is orientated in parallel to the winding axis, wherein the contact assembly in orthogonal projection relative to the winding axis overlaps the first region of the carrier substrate which is wound to form a tube.

The design of the invention of the cuff electrode, involves an application of the contact assembly relative to the carrier substrate region of the cuff electrode, which through a rolling up or winding process takes on the form of a tube and in the implanted state locally surrounds a nerve fiber bundle, which is based on experience gained with a known cuff electrode according to WO 2016/055512 A1. In the known cuff electrode, the region of the film-like carrier substrate which directly and in one piece adjoins the first region of the carrier substrate wound to form a tube, is essentially band or strip-shaped. All electrical lines connected to the electrodes of the cuff electrode extend along the band-shaped carrier substrate region. The band-shaped carrier substrate region has a length essentially orientated in parallel to the winding axis and by way of an orthogonally formed, narrow band section is centrally locally connected to a carrier substrate region wound to form a tube. In the event of tensile or thrust forces acting along the band-like carrier substrate orientated in parallel to the winding axis, asymmetrical forces are exerted on the carrier substrate region wound to form a tube. Along the winding axis, on the one side of the wound carrier substrate, the resulting stress conditions can lead to tighter winding and associated constriction and on the opposite side of the wound carrier substrate region to expansion and associated local unwinding, through which the in dwelling nerve bundle is subjected to significant heterogenic pressure or force effects.

The form of the embodiment in accordance with the invention prevents such stress situations asymmetrically acting on the nerve bundle, in that the contact assembly made of a non-flexible material, for example a ceramic, acts as a type of force coupler, which transmits at least one of tensile and thrust forces acting along at least one of the electrical feed and discharge lines as evenly as possible to the carrier substrate region which is wound to form a tube and is applied around a nerve fiber bundle in a mesh-like manner. Through this, an asymmetrical winding geometry in which one end of the tube acquires a small, and the other end a larger diameter, is also avoided. Preferably force transmission via the contact assembly to the carrier substrate region being wound to form a tube takes place evenly along the entire axial length of the tube. In this way any shear forces acting on the nerve bundle can be avoided. Preferably the contact assembly and the carrier substrate are connected via a joining region that has a joining region length orientated in parallel to the winding length which maximally corresponds to the mutual overlapping between the contact assembly and the tube in an orthogonal projection relative to the winding axis. Here it is particularly advantageous if the longitudinal extent of the contact assembly is equal to or greater than the tube length.

Examples of embodiment are also possible in which the dimensions of the longitudinal extension of the contact assembly, the tube length and the length of the joining region differ from each other, but in these cases it must advantageously be ensured that the contact assembly is firmly joined relative to the carrier substrate so that the longitudinal extension of the contact assembly, the tube length and the length of the joining region each have a common central axis orthogonally orientated relative to the winding axis.

Preferably the contact assembly comprises a plate-like carrier on which the at least one electrical line on the cuff electrode side is in contact with an electrode applied to the carrier, preferably by use of a microflex contact. The electrode on the carrier side is in turn connected to a further electrode surface, applied separately to the carrier, on which at least one of the electrical feed and discharge line leading to the separate supply unit is electrically connected by way of welding, soldering or a bonding connection. On the plate-like carrier there is of course a plurality of such electrode/electrode surface pairs, via which a corresponding number of electric lines on the cuff electrode side are connected to corresponding at least one of feed and discharge lines combined into one cable strand.

The electrical feed and/or discharge line or the plurality of feed and discharge lines combined into one cable strand as well the plate-like carrier is surrounded by an elastic material, which in the joining region is joined to the carrier substrate in a fluid-tight manner. The elastic material which surrounds an electrical feed and/or discharge in a fluid-tight, tube-like or matrix-like manner, forms a strand with a longitudinal extension with a length being determined in accordance with the intracorporeally separate positioning of the cuff electrode and the supply unit.

Compared to the carrier width, the plate-like carrier has a much larger dimensioned carrier length having a longitudinal extent which is orientated parallel to the winding axis. The comparatively narrow carrier shape is preferably dimensioned in such a way that it is embedded within the strand, along which the at least one of a feed and discharge line is integrated, without a substantial change in shape. A specific form of embodiment is explained below in more detail.

In a preferred form of embodiment, for the purpose of additional force distribution of the forces acting on the nerve fiber bundle via the cuff electrode, at least one additional fastening, in the form of a wound cuff or a helical structure, is applied adjacent to the cuff electrode along the strand or tube containing at least one of the electrical feed and the discharge line. The additional fastening comprises, like the cuff electrode, a straight cylindrical cavity, which is aligned coaxially to the winding axis.

In a further preferred form of embodiment, in the longitudinal extension of the strand, the strand or tube envisages a strand prolongation which adjoins the contact assembly and on which a second fastening of the type of the aforementioned first fastening is formed and applied. In this way at least one of the tensile and thrust forces acting along at least one of the feed and the discharge line can be deflected or transmitted symmetrically distributed in relation to the force-electrode assembly along the nerve bundle.

All electrical conductor structures applied on the carrier substrate, including the at least one electrode surface as well as the at least one electrical line electrically connected to the electrode surface are each produced in one piece, preferably by way of a metal deposition process, so that there are no joining points and associated discontinuous electrical impedance differences along the electrical conductor structure.

BRIEF DESCRIPTION OF THE DRAWING

The invention will be described below without restricting the general inventive concept by way of an example of embodiment with reference to the drawing. In this:

FIG. 1 shows an example of embodiment of a medical implant designed in accordance with the invention.

DESCRIPTION OF THE INVENTION

FIG. 1 shows a cuff electrode 1 configured in the manner of a wound cuff electrode assembly with film-like carrier substrate 2, which preferably is made of a polyimide film. The carrier substrate 2 comprises two regions 3, 4 connected in one piece. The first region 3 of the carrier substrate 2 is wound about a winding axis 5. This first region 3 of the carrier substrate 2 which is wound to form a tube keeps a wound-up shape due to tensile forces inherent in the material which have been imparted through an appropriate treatment of the film-like carrier substrate 2. For example, by use of thermal treatment a straight cylindrical cavity 6 is formed which is axially open at both sides. Applied on the surface, facing the straight cylindrical cavity 6, of the first region 3 of the carrier substrate 2 wound to form a tube, is at least one electrode surface 7, and preferably a plurality of such electrode surfaces. Each electrode surface is directly in physical contact with the outer wall of a nerve fiber bundle, which is not shown in more detail. Each of the electrode surfaces 7 is in one-piece contact with an electrical line 8. All surfaces 7 extend inside the carrier substrate 2 in an electrically insulated manner.

The second region 4 of the carrier substrate 2, which directly adjoins the first region 3 of the carrier substrate 2 in one piece, comprises a lateral edge 9, facing away from the first region 3, along which the electrical lines 8 end arranged next to each other and are each, via a microflex contact 10, in contact with an electrode applied on the contact assembly 11. The contact assembly 11 is configured in the form of a plate-like carrier 12, preferably comprising a ceramic plate, and has a longitudinal extension 13. The length of the carrier 12 is much greater than its width.

The electrodes applied on the plate-shaped carrier 12 connect each of the electrical leads 8 to an electrical contact surface 14, which is on the upper side of the plate-shaped carrier 12, and on which by way of a soldered, bonded or welded connection, at least one of an electrical feed and discharge line 15 is in contact and in the picture according to FIG. 1 leads off to the left laterally to the contact assembly 11. All feed and discharge lines 15 connected to the respective contact surface 14 are combined into a cable strand 15* which leads to supply unit 16 formed separately from the cuff electrode 1 which provides, for example, control signals as well as electrical energy for operating the cuff electrode 1. The wire-like feed and discharge lines 15 combined into cable strand 15* are connected to the supply unit 16 via a fluid-tight plug connection (not shown) for a separate manipulation of the supply unit 16, as for example replacement. For electrical insulation as well as for protection against the moist intracorporeal environment, the cable strand 15*, which comprises all the at least one electrical feed and discharge lines 15, is surrounded by a silicone tube 17 or embedded in a silicone strand 17.

In order to ensure that tensile or thrust forces 18 acting along the silicone strand 17 act distributed as evenly as possible along the entire length 19 of the first region 3 of the carrier substrate 2 wound to form a tube, the joining region 20 between the contact assembly 11 and the second region 4 of the carrier substrate 2, in which the carrier substrate 2 is joined by way of a firm joint connection to the surface of the plate-shaped carrier 12 of the contact assembly 11, is arranged in orthogonal projection relative to the winding axis 5 at least partially, and preferably completely, as shown in FIG. 1, overlapping relative to the axial extension 19 of the area 3 of the carrier substrate 2 wound to form a tube. Irrespective of the actual dimensions of the respective lengths of the contact assembly 11, the joining region 20 and first region 3 of the carrier substrate 2 wound to form a tube, the longitudinal extension (13) of the contact assembly (11), the tube length (19) as well as the joining region length (21) preferably have a common middle axis (24) orientated orthogonally relative to the winding axis (5).

In FIG. 1, the joining region 20 has a longitudinal extension 21 which approximately corresponds with the length 19 of the region 3 of the carrier substrate 2 wound to form a tube. In this case, force transmission by the contact assembly 11 onto the carrier substrate 2 takes place via the joining region 20 evenly over the entire length 19.

Optionally a fastening means 22, 22′ can be provided along the winding axis 5 unilaterally relative to the cuff electrode 1 or bilaterally relative to the cuff electrode 1, which like the cuff electrode 1 can nestle around the outer circumference of a nerve bundle under the exertion of force. The fastening means 22, 22′ can be in the form of a wound cuff or a known helical structure, preferably made of a silicone material. The left fastening means 22 in FIG. 1 is applied directly to the silicone strand 17 by a connection 23. The connection 23 is preferably in designed as a one-piece bonded connection, that is the fastening 22, the connection 23 as well as the silicone strand 17 are produced from the same material as part of a uniform manufacturing process. The connection 23 can be configured in the form of a seamless transition between the silicone strand 17 and fastening means 22 up to a special joining geometry, e.g. in the form of a rectilinear, zig-zag, spiral or helical connection arm. The also optionally provided fastening means 22′ on the right side of the cuff electrode 1 is applied on a strand prolongation 17. In this case too, the connection 23′ can be designed in the same way as described above.

LIST OF REFERENCES

-   1 Cuff electrode -   2 Carrier substrate -   3 First region of the carrier substrate -   4 Second region of the carrier substrate -   5 Winding axis -   6 Straight cylinder cavity -   7 Electrode surface -   8 Electrical line -   9 Connection end edge of the carrier substrate -   10 Microflex contact -   11 Contact assembly -   12 Plate-like carrier -   13 Longitudinal extension of the contact assembly -   14 Electrode surface -   15 Electrical feed and/or discharge -   15* Cable strand -   16 Supply unit -   17 Silicone strand -   17′ Strand prolongation -   18 Thrust-tensile forces -   19 Length of the second region 3 of the carrier substrate wound to     form a tube -   20 Joining region -   21 Length of the joining region -   22, 22′ Fastening -   23, 23′ Connection -   25 Middle axis 

1.-9. (canceled)
 10. A medical implant configured as a wound cuff electrode comprising: a flexible, biocompatible, film carrier substrate, which in a first region, is wound about a winding axis, which is shaped as a tube having a length, the tube comprising a straight, cylindrical cavity which is delimited radially relative to the winding axis, on which at least one electrode surface is applied, at least one electrical line integrated within the carrier substrate, connected to a non-flexible contact on which the at least one electrical line is connected to at least one of an electrical feed and discharge line which extends to an implantable electrical supply unit which is separated from the implant; wherein the contact assembly has a spatial longitudinal extension which is orientated in parallel to the winding axis, the contact assembly is joined to the carrier substrate along a joining region, which has an area having a length orientated in parallel to the winding axis, and the contact assembly projects orthogonally relative to the winding axis which overlaps the first region of the carrier substrate.
 11. The medical implant according to claim 10, wherein: the contact assembly is configured relative to the carrier substrate in so that the longitudinal extension of the contact assembly and the tube length of the first region of the carrier substrate wound to have an overlap in orthogonal projection relative to the winding axis.
 12. The medical implant according to claim 10, comprising: the joining region between the contact assembly and the control assembly has a length orientated parallel to the winding axis, which is a maximum at a mutual overlapping of the longitudinal extension of the contact assembly and the length of this tube in orthogonal projection relative to the winding axis.
 13. The medical implant according to claim 11, comprising: the joining region between the contact assembly and the control assembly has a length orientated parallel to the winding axis, which is a maximum at a mutual overlapping of the longitudinal extension of the contact assembly and the length of this tube in orthogonal projection relative to the winding axis.
 14. The medical implant according to claim 10, wherein the contact assembly is joined to the carrier substrate with the longitudinal length of the contact assembly, the tube length and a length of the joining region each have a common middle axis orientated orthogonally relative to the winding axis.
 15. The medical implant according to claim 11, wherein the contact assembly is joined to the carrier substrate with the longitudinal length of the contact assembly, the tube length and a length of the joining region each have a common middle axis orientated orthogonally relative to the winding axis.
 16. The medical implant according to claim 12, wherein the contact assembly is joined to the carrier substrate with the longitudinal length of the contact assembly, the tube length and a length of the joining region each have a common middle axis orientated orthogonally relative to the winding axis.
 17. The medical implant according to claim 13, wherein the contact assembly is joined to the carrier substrate with the longitudinal length of the contact assembly, the tube length and a length of the joining region each have a common middle axis orientated orthogonally relative to the winding axis.
 18. The medical implant according to claim 10, wherein the carrier substrate includes a second flat carrier substrate region which adjoins the first region including a side edge, which laterally delimits the carrier substrate, on which the at least one electrical line is electrically connected to the contact within the joining region.
 19. The medical implant according to claim 12, wherein the carrier substrate includes a second flat carrier substrate region which adjoins the first region including a side edge, which laterally delimits the carrier substrate, on which the at least one electrical line is electrically connected to the contact within the joining region.
 20. The medical implant according to claim 14, wherein the carrier substrate includes a second flat carrier substrate region which adjoins the first region including a side edge, which laterally delimits the carrier substrate, on which the at least one electrical line is electrically connected to the contact within the joining region.
 21. The medical implant according to claim 10, wherein the contact assembly includes a plate carrier on which the at least one electrical lead contacts an electrical contact, with at least one of the electrical feed and the discharge line being electrically connected; and at least one of the electrical feed and the discharge line together with the plate carrier are surrounded by an elastic material which in a joining region is joined to the carrier substrate to be fluid-tight.
 22. The medical implant according to claim 12, wherein the contact assembly includes a plate carrier on which the at least one electrical lead contacts an electrical contact, with at least one of the electrical feed and the discharge line being electrically connected; and at least one of the electrical feed and the discharge line together with the plate carrier are surrounded by an elastic material which in a joining region is joined to the carrier substrate to be fluid-tight.
 23. The medical implant according to claim 14, wherein the contact assembly includes a plate carrier on which the at least one electrical lead contacts an electrical contact, with at least one of the electrical feed and the discharge line being electrically connected; and at least one of the electrical feed and the discharge line together with the plate carrier are surrounded by an elastic material which in a joining region is joined to the carrier substrate to be fluid-tight.
 24. The medical implant according to claim 18, wherein the contact assembly includes a plate carrier on which the at least one electrical lead contacts an electrical contact, with at least one of the electrical feed and the discharge line being electrically connected; and at least one of the electrical feed and the discharge line together with the plate carrier are surrounded by an elastic material which in a joining region is joined to the carrier substrate to be fluid-tight.
 25. The medical implant according to claim 21, wherein the elastic material surrounding at least one of the at least one electrical feed and the discharge line is a strand including a longitudinal extension immediately adjoining the contact assembly, is parallel to the winding axis, and including a region of the strand containing at least one of the electrical feed and discharge line, a first fastener comprising a straight cylindrical cavity having a wound cuff or a helix with the straight cylindrical cavity being coaxially relative to the winding axis.
 26. The medical implant according to claim 25, wherein the longitudinal extension of the strand includes an extension opposite to the contact assembly includes a second fastener.
 27. The medical implant according to claim 10, wherein the first region of the carrier substrate has at least one winding around the winding axis which has at least one region in which the carrier substrate moveably overlaps itself radially relative to the winding axis.
 28. The medical implant according to claim 11, wherein the first region of the carrier substrate has at least one winding around the winding axis which has at least one region in which the carrier substrate moveably overlaps itself radially relative to the winding axis.
 29. The medical implant according to claim 12, wherein the first region of the carrier substrate has at least one winding around the winding axis which has at least one region in which the carrier substrate moveably overlaps itself radially relative to the winding axis. 